Sterilization Pouch and Roll
K-Number: K243179 · 2025-06-26
Decision Date2025-06-26
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Sterilization Pouch and Roll is a medical device manufactured by Yichang Xinxin Paper Products Co., Ltd.. It received FDA 510(k) clearance on 2025-06-26 under approval number K243179. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sterilization Pouch and Roll?
Sterilization Pouch and Roll is a medical device that received FDA 510(k) clearance on 2025-06-26. It is manufactured by Yichang Xinxin Paper Products Co., Ltd.. The 510(k) number is K243179.
When was Sterilization Pouch and Roll approved by the FDA?
Sterilization Pouch and Roll received FDA 510(k) clearance on 2025-06-26, under approval number K243179.
What company makes Sterilization Pouch and Roll?
Sterilization Pouch and Roll is manufactured by Yichang Xinxin Paper Products Co., Ltd..
What is the FDA product code for Sterilization Pouch and Roll?
The FDA product code for Sterilization Pouch and Roll is FRG.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.